OncoMatch/Clinical Trials/NCT06102902
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
Is NCT06102902 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Cetuximab and BET Bromodomain Inhibitor ZEN-3694 for metastatic colorectal adenocarcinoma.
Treatment: BET Bromodomain Inhibitor ZEN-3694 · Cetuximab · Encorafenib — This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins. When ZEN003694 binds to BET proteins, it disrupts gene expression. Preventing the expression of certain growth-promoting genes may inhibit proliferation of tumor cells that over-express BET proteins. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Encorafenib is an enzyme inhibitor. It inhibits pathways that are responsible for controlling cell proliferation and survival, which may lead to a decrease in tumor cell proliferation. Both cetuximab and encorafenib have been approved to treat cancer. Adding ZEN003694 to cetuximab and encorafenib may be more effective at treating patients with refractory metastatic colorectal cancer than giving the usual treatment (cetuximab and encorafenib) alone.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF v600e
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic treatment — incurable advanced or metastatic disease
Patients must have progressed after at least 1 prior systemic treatment for incurable advanced or metastatic disease
Must have received: combination of encorafenib and cetuximab (encorafenib, cetuximab)
Patients must have received prior treatment with the combination of encorafenib and cetuximab. They must have tolerated the combination at doses planned for the study
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin (Hb) ≥ 9 mg/dl
Kidney function
Creatinine clearance (CrCL) GFR ≥ 50 mL/min/1.73 m^2
Liver function
Total bilirubin ≤ 1.5 mg/dl (excluding Gilbert's disease); AST/ALT ≤ 3 x institutional ULN
Cardiac function
NYHA Functional Classification class II or better
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin (Hb) ≥ 9 mg/dl; Total bilirubin ≤ 1.5 mg/dl (excluding Gilbert's disease); AST/ALT ≤ 3 x institutional ULN; Creatinine clearance (CrCL) GFR ≥ 50 mL/min/1.73 m^2; ... cardiac risk assessment ... NYHA Functional Classification class II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Irvine Health Cancer Center-Newport · Costa Mesa, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06102902 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic treatment and combination of encorafenib and cetuximab.
Does this trial require BRAF?
Yes, BRAF v600e is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages